Variation in histopathological assessment and association with surgical quality indicators following oesophagectomy.

BACKGROUND: Histopathological outcomes, such as lymph node yield and margin positivity, are used to benchmark and assess surgical centre quality, and are reported annually by the National Oesophago-Gastric Cancer Audit (NOGCA) in England and Wales. The variation in pathological specimen assessment and how this affects these outcomes is not known. METHODS: A survey of practice was circulated to all tertiary oesophagogastric cancer centres across England and Wales. Questions captured demographic data, and information on how specimens were prepared and analysed. National performance data were retrieved from the NOGCA. Survey results were compared for tertiles of lymph node yield, and circumferential and longitudinal margins. RESULTS: Survey responses were received from 32 of 37 units (86 per cent response rate), accounting for 93.1 per cent of the total oesophagectomy volume in England and Wales. Only 5 of 32 units met or exceeded current guidelines on specimen preparation according to the Royal College of Pathologists guidelines. There was wide variation in how centres defined positive (R1) margins, and how margins and lymph nodes were assessed. Centres with the highest nodal yield were more likely to use systematic fat blocking, and to re-examine specimens when the initial load was low. Systematic blocking of lesser curve fat resulted in significantly higher rates of patients with at least 15 lymph nodes examined (91.4 versus 86.5 per cent; P = 0.027). CONCLUSION: Preparation and histopathological assessment of specimens varies significantly across institutions. This challenges the validity of currently used surgical quality metrics for oesophageal and other tumours.

Association of Discretionary Hospital Volume Standards for High-risk Cancer Surgery With Patient Outcomes and Access, 2005-2016.

Importance: Various clinical societies and patient advocacy organizations continue to encourage minimum volume standards at hospitals that perform certain high-risk operations. Although many clinicians and quality and safety experts believe this can improve outcomes, the extent to which hospitals have responded to these discretionary standards remains unclear. Objective: To evaluate the association between short-term clinical outcomes and hospitals' adherence to the Leapfrog Group's minimum volume standards for high-risk cancer surgery. Design, Setting, and Participants: Longitudinal cohort study using 100% of the Medicare claims for 516 392 patients undergoing pancreatic, esophageal, rectal, or lung resection for cancer between January 1, 2005, and December 31, 2016. Data were accessed between December 1, 2018, and April 30, 2019. Exposures: High-risk cancer surgery in hospitals meeting and not meeting the minimum volume standards. Main Outcomes and Measures: Patients having surgery in hospitals meeting the volume standard and 30-day and in-hospital mortality and complication rates. Results: Overall, a total of 516 392 procedures (47 318 pancreatic resections, 29 812 esophageal resections, 116 383 rectal resections, and 322 879 lung resections) were included in the study, and patient mean (SD) age was 73.1 (7.5) years. Outcomes improved over time in both hospitals meeting and not meeting the minimum volume standards. Mortality after pancreatic resection decreased from 5.5% in 2005 to 4.8% in 2016 (P for trend <.001). Mortality after esophageal resection decreased from in 6.7% 2005 to 5.0% in 2016 (P for trend <.001). Mortality after rectal resection decreased from 3.6% in 2005 to 2.7 % in 2016 (P for trend <.001). Mortality after lung resection decreased from 4.2% in 2005 to 2.7 % in 2016 (P for trend <.001). Throughout the study period, there were no statistically significant differences in risk-adjusted mortality between hospitals meeting and not meeting the volume standards for esophageal, lung, and rectal cancer resections. Mortality rates after pancreatic resection were consistently lower at hospitals meeting the volume standard, although mortality at all hospitals decreased over the study period. For example, in 2016, risk-adjusted mortality rates for hospitals meeting the volume standard were 3.8% (95% CI, 3.3%-4.3%) compared with 5.7% (95% CI, 5.1%-6.5%) for hospitals that did not. Although an increasing majority of patients underwent surgery in hospitals meeting the Leapfrog volume standards over time, the overall proportion of hospitals meeting the standards in 2016 ranged from 5.6% for esophageal resection to 23.3% for pancreatic resection. Conclusions and Relevance: Although volume remains an important factor for patient safety, the Leapfrog Group's minimum volume standards did not differentiate hospitals based on mortality for 3 of the 4 high-risk cancer operations assessed, and few hospitals were able to meet these standards. These findings highlight important tradeoffs between setting effective volume thresholds and practical expectations for hospital adherence and patient access to centers that meet those standards.

Assessment of the quality of surgery within randomised controlled trials for the treatment of gastro-oesophageal cancer: a systematic review.

Multicentre, randomised, controlled trials (RCTs) provide level 1 evidence for surgery in the treatment of gastro-oesophageal cancer. This systematic review investigated whether standardisation of surgical techniques in RCTs reduces the variation in lymph-node harvest, in-hospital mortality, and locoregional cancer recurrence. The range in the coefficients of variation for lymph-node harvest (0.07-0.61), proportion of patients with locoregional cancer recurrence (1.1-46.2%), and in-hospital mortality (0-10%) was wide. Credentialing of surgeons through assessment of operative reports and monitoring of their performance through data collection were important factors that reduced the variation in lymph-node harvest. Factors that reduced adjusted in-hospital mortality included credentialing surgeons through procedural volume and operative reports, and standardisation of surgical techniques. Future RCTs should include an assessment of surgical performance as an important aspect of study design to reduce variation in clinical outcomes.

The 30-day versus in-hospital and 90-day mortality after esophagectomy as indicators for quality of care.

OBJECTIVE: To describe causes of death in the first year after esophagectomy and determine the time frame that should be used for measurement of quality of surgery. A case-mix adjustment model was developed for the comparison between hospitals. BACKGROUND: The time period in which postoperative mortality should be measured as a performance indicator is debated. METHODS: Cause of death was identified for patients in a tertiary referral hospital who died within 1 year after surgery and classified as surgery related or not surgery related. Sensitivity and specificity for detecting deaths related to surgery were calculated for different periods of follow-up. Case-mix adjustment models for 30-day mortality (30DM), in-hospital mortality, and 90-day mortality (90DM) were developed. RESULTS: In total, 1282 patients underwent esophagectomy. 30DM was 2.9%, the in-hospital mortality rate was 5.1% and 90DM was 7%. Beyond 30 days, a substantial number of deaths were related to the operation, especially due to anastomotic leakage. Postdischarge nononcological mortality was most frequently caused by sudden death. One in 5 patients died because of recurrent disease, being the most important threat in the first year after surgery. The 30DM had a sensitivity for detecting surgery-related deaths of 33% and a specificity of 100%. The 90DM had a sensitivity of 74% and a specificity of 96%. CONCLUSIONS: A period of postoperative follow-up longer than 30 days needs to be considered when comparing surgical performance between institutes. In the case-mix adjustment model for 90DM, no other variables have to be taken into account compared to those involved in 30DM.

Composite measures for rating hospital quality with major surgery.

OBJECTIVE: To assess the value of a novel composite measure for identifying the best hospitals for major procedures. DATA SOURCE: We used national Medicare data for patients undergoing five high-risk surgical procedures between 2005 and 2008. STUDY DESIGN: For each procedure, we used empirical Bayes techniques to create a composite measure combining hospital volume, risk-adjusted mortality with the procedure of interest, risk-adjusted mortality with other related procedures, and other variables. Hospitals were ranked based on 2005-2006 data and placed in one of three groups: 1-star (bottom 20 percent), 2-star (middle 60 percent), and 3-star (top 20 percent). We assessed how well these ratings forecasted risk-adjusted mortality rates in the next 2 years (2007-2008), compared to other measures. PRINCIPAL FINDINGS: For all five procedures, the composite measures based on 2005-2006 data performed well in predicting future hospital performance. Compared to 1-star hospitals, risk-adjusted mortality was much lower at 3-star hospitals for esophagectomy (6.7 versus 14.4 percent), pancreatectomy (4.7 versus 9.2 percent), coronary artery bypass surgery (2.6 versus 5.0 percent), aortic valve replacement (4.5 versus 8.5 percent), and percutaneous coronary interventions (2.4 versus 4.1 percent). Compared to individual surgical quality measures, the composite measures were better at forecasting future risk-adjusted mortality. These measures also outperformed the Center for Medicare and Medicaid Services (CMS) Hospital Compare ratings. CONCLUSION: Composite measures of surgical quality are very effective at predicting hospital mortality rates with major procedures. Such measures would be more informative than existing quality indicators in helping patients and payers identify high-quality hospitals with specific procedures.

Kaizen method for esophagectomy patients: improved quality control, outcomes, and decreased costs.

BACKGROUND: The majority of costs associated with esophagectomy are related to the initial 3 days of hospital stay requiring intensive care unit stays, ventilator support, and intraoperative time. Additional costs arise from hospital-based services. The major cost increases are related to complications associated with the procedure. We attempted to define these costs and identify expense management by streamlining care through strict adherence to patient care maps, operative standardization, and rapid discharge planning to reduce variability. METHODS: Utilizing methods of Kaizen philosophy we evaluated all processes related to the entire experience of esophageal resection. This process has taken over 5 years to achieve, with quality and cost being tracked over this time period. Cost analysis included expenses related to intensive care unit, anesthesia, disposables, and hospital services. Quality improvement measures were related to intraoperative complications, in-hospital complications, and postoperative outcomes. The Institutional Review Board approved the use of anonymous data from standard clinical practice because no additional treatment was planned (observational study). RESULTS: Utilizing a continuous process improvement methodology, a 43% reduction in cost per case has been achieved with a significant increase in contribution margin for esophagectomy. The length of stay has been reduced from 14 days to 5. With intraoperative and postoperative standardization the leak rate has dropped from 12% to less than 3% to no leaks in our current Kaizen modification of care in our last 64 patients. CONCLUSIONS: Utilizing lean manufacturing techniques and continuous process evaluation we have attempted to eliminate variability, standardized the phases of care resulting in improved outcomes, decreased length of stay, and improved contribution margins. These Kaizen improvements require continuous interventions, strict adherence to care maps, and input from all levels for quality improvements.

Control chart methods for monitoring surgical performance: a case study from gastro-oesophageal surgery.

Graphical methods are becoming increasingly used to monitor adverse outcomes from surgical interventions. However, uptake of such methods has largely been in the area of cardiothoracic surgery or in transplants with relatively little impact made in surgical oncology. A number of the more commonly used graphical methods including the Cumulative Mortality plot, Variable Life-Adjusted Display, Cumulative Sum (CUSUM) and funnel plots will be described. Accounting for heterogeneity in case-mix will be discussed and how ignoring case-mix can have considerable consequences. All methods will be illustrated using data from the Scottish Audit of Gastro-Oesophageal Cancer services (SAGOCS) data set.

Surgery for oesophageal cancer at Galway University Hospital 1993-2008.

BACKGROUND: Surgical volume and outcome remain controversial in the management of oesophageal cancer. AIMS: To assess the outcome of oesophagectomy for cancer at Galway University Hospital (GUH). METHODS: Between 1994 and 2008, patients who underwent oesophagectomy were analysed. RESULTS: During the study period, 126 oesophagectomies were performed for cancer. The average surgeon volume was 9 cases per year. The 30-day and overall in-hospital mortality rates were 6.3 and 7.9%, respectively. Restructuring of our critical care services has led to a reduction in 30-day mortality from 8.2 to 5.1%. The use of neoadjuvant chemoradiotherapy has increased from 17 to 35% during the study period. In patients who underwent resection, the 3 and 5-year overall survival rates were 45 and 29%, respectively. CONCLUSIONS: Operative morbidity and mortality at GUH are comparable with worldwide outcomes. Improved resources and national restructuring of cancer services have significantly improved the quality of care and outcomes of patients.

Small rural hospitals and high-risk operations: how would regionalization affect surgical volume and hospital revenue?

BACKGROUND: Because higher hospital procedure volume is associated with better outcomes for many high-risk procedures, regionalization to higher-volume hospitals has been proposed as a way to improve quality of surgical care. The potential impact of such policies on small rural hospital volume and revenue is unknown. STUDY DESIGN: We identified all hospitalizations in small rural hospitals (less than 50 beds) in New York State from 1998 to 2001 that included an ICD-9 procedure code for 1 of 9 procedures for which there is a documented volume-outcomes association: abdominal aortic aneurysm repair, aortic-valve replacement, carotid endarterectomy, colectomy, coronary artery bypass, cystectomy, esophagectomy, pancreatectomy, or pulmonary resection. Revenue from these procedures was estimated using gross charges and payor-specific reimbursement rates. We then compared these estimates with total hospital inpatient revenue for each rural hospital. RESULTS: We identified 14 small rural hospitals where at least one of the nine procedures was performed. All included hospitalizations for colectomy. Aortic aneurysm repairs, cystectomies, and pancreatectomies were performed in three hospitals; carotid endarterectomy in two; and esophagectomy in one. In no hospitals were cardiac procedures or pulmonary resections performed. Estimated average contribution to hospital net revenue for all 9 procedures was approximately 2%, nearly all attributable to colectomy. CONCLUSIONS: If all aortic aneurysm repairs, major cardiothoracic procedures, carotid endarterectomies, cystectomies, and pancreatectomies in New York State were regionalized to higher-volume hospitals, no small rural hospitals would experience substantial impact in terms of rural hospital procedure volume and revenue. Even regionalization of colectomy would have a small impact on inpatient volume and revenue.

Selection for oesophagectomy and postoperative outcome in a defined population.

OBJECTIVE: To measure the extent of use of, and perioperative mortality from, oesophagectomy for carcinoma of the oesophagus, and to examine the association between oesophagectomy and long term survival. DESIGN: Retrospective cohort study of cases of oesophageal carcinoma notified to the Thames Cancer Registry. SETTING: South East Thames and South West Thames health regions. PATIENTS: 3273 patients first registered with carcinoma of the oesophagus during 1985-9, 789 of whom were excluded because of incomplete data, leaving 2484 (75.9%) for further analysis. MAIN MEASURES: Treatment of oesophagectomy, mortality within 30 days of oesophagectomy, and duration of survival from date of diagnosis to death, according to patient and tumour characteristics. RESULTS: Oesophagectomy was performed in 571(23.0%) patients. Its use decreased with increasing age (odds ratio (95% confidence interval) 0.935(0.925 to 0.944) per year) and was less common for tumours of the middle or upper third of the oesophagus than the lower third (0.56(0.42 to 0.75)). The proportion of patients undergoing oesophagectomy varied threefold among the 28 districts of residence. The perioperative mortality rate was 15.1(86/571) (12% to 18%); it increased with age (odds ratio 1.05(1.02 to 1.08) per year) and for tumours of the middle or upper third of the oesophagus compared with the lower third (2.52(1.31 to 4.84)). Long term survival was slightly higher for patients undergoing oesophagectomy (0.5% v 0.2%). CONCLUSIONS: Despite a high perioperative mortality rate patients selected for oesophagectomy showed better long term survival than those who were not, suggesting that clinical judgements used in selection were independent markers of a better prognosis. The nature of this selection needs to be more completely characterised to permit a valid evaluation of outcome of oesophagectomy.